UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001366 |
|---|---|
| Receipt number | R000001660 |
| Scientific Title | Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty |
| Date of disclosure of the study information | 2008/09/11 |
| Last modified on | 2008/09/10 11:16:15 |
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Basic information
Public title
Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty
Acronym
J-PSVT
Scientific Title
Clinical study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty
Scientific Title:Acronym
J-PSVT
Region
| Japan |
Condition
Condition
Venous Thromboembolism
Osteoarthrosis
Classification by specialty
| Cardiology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to investigate the actual situation of the prophylactic in this country for the vein thromboembolism(VTE)to break out after total joint arthroplasty and inspects the VTE onset protective efficacy of each prophylactic and is aimed at establishing a VTE appropriate(total joint arthroplasty to) a Japanese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The DVT that was confirmed by sonography of Day10(No symptom characteristics).
DVT/PE symptom that broke out by Day25.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patient who is older than 20 years
old for total joint arthroplasty of
lower limbs plan cases in NHO
institution orthopedics from July,2008
to December,2009.
2.The patient that an agreement by the
document was provided.
Key exclusion criteria
1.A patient with the past of the blood
dyscrasia(a ProteinC,S,AT-3 deficiency
disease,an antiphosphatide antibody
syndrome,hemophilia)with the
solldification abnormality.
2.A atient having tha hemorrhagic mental
change caused by a disease(tha
hemorrhagic mental changes caused by a
disease of the important
internalorgans such as a digestive
ulcer,the bleeding in the skull).
3.Heart failure(NYHA classification
ciass 3 or 4)
4.Renal insufficiency(less than 30ml/min
creatinine clearance)
5.Liver function disorder(more than AST
institution standard upper limit 5
times or more than 3 times of the ALT
upper limit and total bilirubin,more
than 2 times of the upper limit).
6.The patient who plan to have
simultaneous Total joint anthroplasty
for both side.
7.The patient that Total joint
arthroplasty was enforced within the
past three months,or revisit.
8.The patient whom the chief physician
recognizes as inappropriateness for
this study participation.
9.The patient who tries artificial
feeding(tubal feeding,central vein
nourishment).
10.The patient who is not able to walk.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Motokawa |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-1001-1 Kubara Omura City Nagasaki 856-8562 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2008 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine a difference of the onset frequency of postoperative vein thromboembollsm by the kind of the preventer.
Management information
Registered date
| 2008 | Year | 09 | Month | 10 | Day |
Last modified on
| 2008 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
